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Closure of Mucosal and Submucosal Defects in the Gastrointestinal Tract Using the Novel X-Tack Endoscopic Suturing Device

NCT04925271 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2023-06-28

Study results available
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Summary

After removing large polyps from the gastrointestinal tract, gastroenterologists close the new defect with devices to prevent complications like bleeding or the development of a leak. Commonly, this is done with a device called Overstitch, which allows the gastroenterologist to stitch the defect with an endoscope. A new device called X-tack has been developed to simplify endoscopic stitching. In this study, the new X-tack device will be compared to Overstitch when closing defects in the gastrointestinal tract. The two devices will be compared to see how long it takes to close a defect, as well as if there are any differences in complications like bleeding or infection.

Conditions

  • Polyp of Colon
  • Fistula

Interventions

DEVICE

X-Tack

The mucosal or submucosal defect is closed with X-Tack.

DEVICE

Overstitch

The mucosal or submucosal defect is closed with Overstitch.

Sponsors & Collaborators

  • Thomas Jefferson University

    lead OTHER

Principal Investigators

  • Anand Kumar, MD MPH · Thomas Jefferson University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-07-01
Primary Completion
2022-06-30
Completion
2022-07-30
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04925271 on ClinicalTrials.gov